Kornimate/medical-research-clean huggingface dataset:
evaluation of the spinner device for the application of wound dressing: treatment of split skin graft donor sites

Conditions: Wound of Skin

Summary: evaluation of safety and performance of the spinner device and wound dressing in the treatment of donor-site wounds (dsw)

the spinner is a hand held, portable electro-spinning device that produces personalized in-situ nanofiber dressings for the treatment of external burns and wounds. the dressing has non-adherence, high absorbance, bacterial protection, easy and pain-free peel characteristics and shows excellent conformability and optimal coverage of the wound. the objective of this study is to evaluate the safety and performance of the spinner device and wound dressing in the treatment of donor-site wounds (dsw) at size of 10-200 cm2. the study will include five sites in israel: sheba medical center, tel hashomer rambammedical center, haifa kaplan medical center, rehovot souraski medical center, tel aviv beilinson medical center, petach tikva study primary endpoints: 1. dermal safety 2. wound healing and time to complete re-epithelialization at 1, 3, 5, 7, 14 and 21 days post operation study secondary endpoints: 1. ease of use 2. pain assessment at 1, 3, 5, 7, 14 and 21 days post operation 3. infection assessment from 3 days post operation up to 21 days 4. device related adverse events of the spinner device and wound dressing extended exploratory follow up: assessment of itching and scarring from wound closure time and up to 12 months follow up

Eligibility criteria:
inclusion criteria: * the patient is ≥ 18 years old at enrolment. both genders. * patients with donor site wound, size of 10-200 cm2, located in the thigh after partial thickness skin-graft * the patient is able and willing to comply with study procedures and give written informed consent prior to enrollment in the study exclusion criteria: * any known or suspected systemic infection * any known sensitivity to components/products used in this study * use of penicillamine, corticosteroid or immunosuppressive medication within two months prior to enrollment, or current use of nonsteroidal anti- inflammatory agents which cannot be discontinued, or who is likely to be prescribed these medications or any other medications known to adversely affect wound healing during study participation * major uncontrolled systemic disorders such as hepatic, renal, neurologic, or endocrinologic disorders. * patients undergoing repeat skin graft harvesting at the same donor site * patients with burns of more than 15% tbsa * requires immersion hydrotherapy at any time during study participation * bleeding disorders * skin disorders such as psoriasis, pemphigus, toxic epidermal necrolysis (ten), stevens-johnson syndrome (sjs), pyoderma gangrenosum and other exfoliative disorders * terminal patients * soldiers * prisoners * female patients who are pregnant or nursing, or of childbearing potential and are not using adequate contraception * participation in another clinical trial within 30 days prior to the screening visit or during this study. * psychiatric patient.

Keywords: nanofibers dressing donor site polycaprolactone
effect of technology on cognitive function in elderly

Conditions: Cognitive Impairment

Summary: cognitive technology therapies, including interactive video gaming, computer soft wares and mobile technology, have been used to implement cognitive training and rehabilitation programs. potential advantages to using technology-based interventions include enhanced accessibility and cost-effectiveness, providing a user experience to be good communicator, immersive and comprehensive.

aging over 60 years is associated with some progressive decline in cognitive domains, such as processing speed and executive function. a significant decline in cognitive function, particularly memory, which is an early symptom of dementia, can lead to mild cognitive impairment (mci). currently it is estimated that 50 million are living with dementia worldwide and nearly 10 million new cases occur every year, representing a serious public health problem. as such, the who has suggested that preventing cognitive decline and dementia is a global mental health priority. in addition to impacting the patient, dementia also has a significant impact on the family and society in general. age is the biggest risk factor for the development of dementia, and aging is associated with a decline of cognitive function. non-pharmacological interventions such as physical exercise and cognitive interventions may offer an alternative to pharmacological intervention in delaying dementia-related functional decline. over the last decade, the accessibility and use of computers, smartphones and mobile internet has quickly expanded . cognitive technology therapies, including interactive video gaming, computer soft wares and mobile technology, have been used to implement cognitive training and rehabilitation programs. potential advantages to using technology-based interventions include enhanced accessibility and cost-effectiveness, providing a user experience to be good communicator, immersive and comprehensive.

Eligibility criteria:
inclusion criteria 1- age ≥ 65 years. 2- literate with ≥ 15 years of education. 3- older adults with mild dementia. 4- montreal cognitive assessment score 18-26 .( pinto et al .,2019). 5- android smartphone user. 6- well ability to write and read. exclusion criteria 1. major cardiovascular events , such as stroke or myocardial infraction in past three months. 2. alzheimer's disease. 3. sever cognitive dementia. 4. sever hearing difficulty or visual disturbance. 5. brain injury. 6. limitation in communications. 7. chronic kidney diseases. 8. liver diseases. 9. low or high educated. 10. uncontrolled diabetic patients. 11. thyroid disturbance. 12. mental and psychological instability .
impact of psychoeducation in quality of life of parents with children with congenital heart defects

Conditions: Congenital Heart Defects

Summary: congenital heart defects (chd) are the most common congenital malformations. despite the progress made in the last decades in diagnosis and treatment, chd continues to be associated with significant morbidity and mortality. several studies have shown a reduction in the quality of life (qol) of parents of children with chd, which may affect children too. the main research aim is to assess and to understand the impact of a psychoeducational intervention in qol of parents with newborns with chd. we are including parents of inpatient newborns in neonatal intensive care unit (nicu) of uag da mulher e criança - centro hospitalar universitário de são joão (chusj) with the diagnosis of non-syndromic chd, between march 2019 and february 2020. we also included parents of newborns born at chusj with the diagnosis of non-syndromic chd, not admited in nicu, between september 2019 and february 2020. the inclusion criteria are: i) parents of newborns (up to 28 days) with the diagnosis of non- syndromic chd; ii) newborns hospitalized in chusj; iii) parents aged ≥ 18 years. parents of newborns with other important co-morbidities associated with chd and those who do not have good understanding and expression in portuguese will be excluded. parents will be divided in 2 study groups: intervention group (i) and control group (c). group i will receive a psychoeducational intervention in addition to the usual routines of the service. group c will receive the usual routines of the service. the psychoeducational intervention, which consists of 2 sessions lasting 90 minutes each one, will be performed as soon as possible after inclusion in the study. participants will be evaluated in three moments: m1 beginning of the study; m2 4 weeks after the intervention (i) or after enrollment (c) and m3 16 weeks after intervention/enrollment. the primary outcome will be parental qol, which will be evaluated through the world health organization quality of life-bref (whoqol-bref). the family impact and the perception of positive contributions will be secondary outcomes. these outcome variables will be assessed by the impact on family scale and the positive contributions scale - kansas inventory of parental perceptions, respectively. a semi-structured interview will be performed after all quantitative data have been collected. the authors expect to find an increase of qol and positive contributions and a decrease of family impact in the intervention group comparatively to the control group.


Eligibility criteria:
inclusion criteria: * parents of newborns (up to 28 days) with the diagnosis of non-syndromic chd; * newborns hospitalized in chusj; * parents aged ≥ 18 years. exclusion criteria: * parents of newborns with other important comorbidities associated with chd; * parents who do not have good understanding and expression in portuguese.

Keywords: congenital heart defects diagnosis parents quality of life education
low-field bedside brain magnetic resonance imaging in pediatric extracorporeal membrane oxygenation

Conditions: Feasibility and Safety of a Low-field MRI; Acute Brain Injury; Extracorporeal Membrane Oxygenation Complication

Summary: the primary object of the study is to further characterize safety and feasibility of low-field bedside mri in pediatric and neonatal ecmo patients. to perform imaging assessments of an early-stage magnetic resonance imaging (mri) system on patients using low field magnetic strength. collect qualitative data from the image assessments to optimize device performance using a low field magnetic resonance imaging device in a simulated use environment; collect qualitative data from the image assessments using a high field magnetic resonance imaging, computed tomography and ultrasound devices. generate anonymized image data for post-acquisition evaluation, performance measuring and planning for subsequent study size


Eligibility criteria:
inclusion criteria * subjects admitted to the pediatric intensive care unit, cardiac intensive care unit, or the neonatal intensive care unit at children's mercy kansas city * ages 0-17 years * undergoing venovenous or venoarterial ecmo exclusion criteria * pregnancy * active implants such as: * pacemaker * implanted defibrillator * implanted insulin pump * deep brain stimulator * vagus nerve stimulator * cochlear implant * programmable shunt * mri incompatible surgical hardware (e.g., staples, screws, etc.) * metal-containing tattoos or permanent make-up on head or neck * suspected metal in eye, e.g., * former or current welders, metal workers, or individuals with a metal injury * metal shrapnel * passive implants are considered mri conditional
endoscopic findings in patients with typical gastroesophageal reflux disease (gerd) symptoms

Conditions: Gastroesophageal Reflux Disease

Summary: gastroesophageal reflux disease (gerd) is diagnosed on the basis of characteristic reflux symptoms (i.e. troublesome heartburn and/or acid regurgitation). empirical therapy without diagnostic endoscopy is suggested for those gerd patients presenting without alarm symptoms in western countries. whether such "treating instead of testing" strategy should be applied in asia, an area with higher prevalence of helicobacter pylori and gastric cancer, remains uninvestigated.

this study amis to investigate upper endoscopic findings of typical acid reflux patients with and without alarm symptoms in taiwan during the period from may 2008 to december 2009, consecutive adult outpatients, who receive upper endoscopy for characteristic reflux symptoms of heartburn or acid regurgitation, are invited to participate. all study participants are evaluated for presence of pre-defined alarm symptoms including odynophagia or dysphagia, gastrointestinal bleeding, involuntary body weight loss and anemia. upper endoscopic procedures are performed with standard electronic videoendoscope (gif-q240 or gif-q260; olympus, tokyo, japan) by experienced endoscopists; each of them had previously performed a minimum of 2,000 upper endoscopy exams. representative images are taken and stored as electronic files in a digital image system for later analysis. the following five significant endoscopic findings are pre-defined endpoints of this study: 1) any malignant lesion in the upper digestive tract, 2) barrett esophagus, 3) severe erosive esophagitis (la grade c or d), 4) peptic stricture, 5) peptic ulcer.

Eligibility criteria:
inclusion criteria: * outpatients * chief complaints of characteristic gerd symptoms (heart burn or acid regurgitation), evaluated by standard questionnaire * undergo upper digestive endoscopy exclusion criteria: * age less than 18 years old or more than 90 years old * unable to complete upper endoscopy * known diagnosis of gastroesophageal malignancy * follow-up visit for known gastroesophageal lesion identified by previous upper endoscopy * failure to obtain informed consent

Keywords: gastroesophageal reflux disease alarm symptoms gastrointestinal endoscopy
effect of whole body periodic acceleration on airway endothelial function

Conditions: Healthy; Smokers; Asthma

Summary: in the present proposal the investigators wish to assess the effect of a single session with the device known as exer-rest® which applies whole body periodic acceleration (wbpa) on baseline airway blood flow (qaw) and in qaw variation, in current smokers, glucocorticoid-naïve asthmatics, and age-matched healthy never-smokers, with the expectation that the treatment will transiently increase the qaw, and to a greater extent in the current smokers and patients with asthma who have endothelial dysfunction.

endothelial shear stress activates nitric oxide synthase (nos), leading to endothelium-dependent vasodilation. this can be accomplished through exercise or with a device known as exer-rest® which applies whole body periodic acceleration (wbpa) that is also called pgz. wbpa produces systemic vasodilation, by exerting shear stress on the vascular endothelium, activating endothelial nos and releasing no in animal models and human subjects. cigarette smoking is associated with attenuated vascular relaxation responses in the systemic circulation. patients with asthma also exhibit endothelial dysfunction in the airway. in this study the investigators wish to assess the effect of a single pgz session on baseline qaw and delta qaw in current smokers, glucocorticoid-naïve asthmatics, and age-matched healthy never-smokers to test if this treatment will increase the vascular relaxation responses.

Eligibility criteria:
inclusion criteria: 15 healthy never-smokers, 15 smokers (\> than 1 year smoke history) and 15 never-smokers asthmatics; fev1 \> 80% (except for asthmatics subjets) exclusion criteria: women of childbearing potential who do not accepted birth control measures; pregnant and breast feeding; cardiovascular disease or use of cardiovascular drugs; respiratory infection during the 4 weeks preceding the study; use of inhaled or systemic glucocorticoids, leukotriene modifiers or theophyllines in asthmatics; fev1 \< 80% on the screening day (excepted for asthmatics subjets)

Keywords: airway blood flow albuterol whole body periodic acceleration (wbpa) nitric oxide endothelial dysfunction
effects of dha on post-operative fibrosis of trabulectomy blebs in glaucoma surgery

Conditions: Trabulectomy; Deep Sclerectomy

Summary: post-operative fibrosis of trabulectomy blebs is a major cause of surgical failure leading to a renewed increase in intraocular pressure. the use of anti-metabolites over many years has made it possible to improve success rates for this surgery but these drugs have numerous adverse effects as they are toxic. alternative therapies are thus necessary, and we believe that dha could have antifibrotic effects on fibroblasts and could thus improve success rates in this surgery.


Eligibility criteria:
inclusion criteria: * patients undergoing trabulectomy or deep sclerectomy * patients informed about the study exclusion criteria: - patients who refuse to take part in the study
randomized clinical trial to evaluate immunogenicity and safety in mexicans newborns

Conditions: Poliomyelitis

Summary: polio is a highly infectious disease caused by a virus. it invades the nervous system, and can cause total paralysis in a matter of hours. the virus enters the body through the mouth and multiplies in the intestine. initial symptoms are fever, fatigue, headache, vomiting, stiffness in the neck and pain in the limbs. one in 200 infections leads to irreversible paralysis (usually in the legs). among those paralysed, 5% to 10% die when their breathing muscles become immobilized. there is no cure for polio, it can only be prevented. polio vaccine, given multiple times, can protect a child for life. compare in newborns the immunogenicity and safety of the vaccine opv produced by birmex compared with the vaccine opv produced by sanofi pasteur, both produced in vero cells.

this is a randomized clinical trial, which includes 320 newborns of both sexes and residents of the state of méxico, 160 newborns receive the vaccine opv birmex and 160 newborns receive the vaccine opv sanofi pasteur

Eligibility criteria:
inclusion criteria: * newborns babies * weight ≥ 2.5 kg * have not received any doses of polio vaccine * whose parents or guardians reside in the work area * whose parent or guardian accept to sign written informed consent (by the other, father or guardian). exclusion criteria: * born of a high-risk pregnancy. * weight ≤ 2.5 kg * presence of fever, diarrhea, known immunosuppression, respiratory infections. * treatment with immunosuppressants. * having neurological diseases. * require or received surgery in oropharynx.

Keywords: immunogenicity safety efficacy poliomyelitis newborn
pain relief of metoprolol versus metoprolol plus morphine in acute chest pain

Conditions: Acute Coronary Syndromes

Summary: the primary aim was to evaluate the relief of chest pain during the first 30 minutes among patients who received metoprolol alone as compared with metoprolol plus morphine


Eligibility criteria:
inclusion criteria: * acute chest pain * ecg-signs indicating myocardial ischemia exclusion criteria: * heart rate \< 60 beats/min * systolic blood pressure \< 110 mmhg * high degree av-block * signs of obstructive pulmonary disease * signs of pulmonary oedema * unwillingness * participation in other studies * long delay between arrival of ambulance and randomisation

Keywords: acute coronary syndrome chest pain betablockers morphine prehospital phase
a randomised, cross-over, relative bioavailability study of nicotine delivery and nicotine extraction from oral products

Conditions: Healthy Volunteers

Summary: this study is a randomised cross-over, open-label, confinement study conducted in 24 male or female snus and cigarette consumers. the study investigates 5 different nicotine containing products in a cross-over fashion. the study incorporates pharmacokinetics evaluation, nicotine extraction evaluation, subjective questionnaire assessments as well as safety evaluation. during the study participation, subjects come for two visits to the clinic, including a 5-day confinement period.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) ≥ 18.0 and ≤ 30.0 kg/m * clinically normal medical history, physical findings, vital signs, ecg and laboratory values at the time of screening, as judged by the investigator * dual user of snus and conventional cigarettes for ≥1 year, with a minimum weekly consumption of two or more snus cans and \>5 cigarettes, and who is willing and able to use brands with nicotine content ≥1% exclusion criteria: * history of any clinically significant disease or disorder * any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first use of ip * positive for hiv, hepatitis b or c * after 10 minutes supine rest at the time of screening, any vital signs values outside the following ranges: * systolic blood pressure \ 140 mmhg, or * diastolic blood pressure \ 90 mmhg, or * pulse \ 90 bpm * alcohol or drug abuse * use, or history of use of anabolic steroids * allergy/hypersensitivity to drugs with a similar chemical structure or class to nicotine * excessive caffeine consumption (daily intake of \>5 cups) * female subjects who are pregnant or breastfeeding
clinical efficacy of onetouch® verio™iq meter

Conditions: Diabetes Mellitus

Summary: diabetes mellitus is one of the most prevalent disease in the western world. the control of glucose levels has a big impact in the prevention of diabetes complications. the measure of glucose levels in capillary blood with glucometers is the gold standard to measure and control the glucose levels. nowadays the glucometers become to more precise and sophisticated devices. one of the most notables advance is the inclusion of software that cam predicts glucose trends. this software has not be tested in routine clinical practice.


Eligibility criteria:
inclusion criteria: * patient diagnosed with diabetes mellitus 1 or 2 * treatment with insulin regimen during at least 12 months * capability of performed 3 glucose measurement per day * levels of glycated hemoglobin (a1c) less than 10% exclusion criteria: * patients diagnosed of mental disorders * patients included in structured therapeutic health 6 months before the inclusion * patients included in any clinical trial in the 4 months before the inclusion
a trial to assess the safety, tolerability and pharmacokinetics of mdt-637 in healthy volunteers

Conditions: Drug Safety

Summary: the purpose of the study is to assess the tolerability and safety of a range of repeated inhaled doses of mdt-637. this includes monitoring effects on pulmonary function and determination of blood levels of mdt-637 following inhalation.


Eligibility criteria:
inclusion criteria: * males and/or surgically sterile or post-menopausal females (confirmed by fsh test); males must agree to practice barrier contraception until they are discharged from the study * willing to give written informed consent * 18 to 50 years of age * bmi of 19-30 kg/m2 * non-smoker (for at least 90 days prior to screening) and willing to abstain from smoking during the course of the study * good general health as determined by medical history, physical examination, spirometry, ecg and clinical laboratory tests * willing to abstain from alcohol, caffeine, and xanthine-containing beverages for 24 hours prior to and 24 hours after dosing exclusion criteria: * uncontrolled, clinically significant disease which in the opinion of the principal investigator and sponsor (mdtx) would place the subject at risk through study participation or would confound the assessment of the safety of mdt-637 * evidence of current or history of respiratory disease; for instance asthma, emphysema, chronic bronchitis or cystic fibrosis. * upper respiratory tract infection within 6 weeks of visit 1 * symptoms of rhinitis (stuffy nose, rhinorrhea, sneezing, nasal discharge) within 2 weeks of visit 1 * current symptoms of cough, dyspnea, wheezing or nocturnal awakenings due to respiratory symptoms * history of significant nasal irritation from nasal inhalation of medication * history of malignancy * history of clinically significant alcohol or drug abuse * positive drug screen for drugs of abuse * positive test for hiv, hepatitis b or hepatitis c * allergy to lactose, or lactose intolerance * use of prescription medication within 14 days of visit 2 or over-the-counter preparations, including dietary and herbal supplements, within 5 days of visit 2 * positive urine pregnancy test at visit 1 * inability to perform reproducible spirometry in accordance with american thoracic society/european respiratory society (ats/ers) guidelines * abnormal qtc interval at visit 1(\>450 msec in males or \> 470 msec in females) * significant blood donation (or testing) in previous 8 weeks

Keywords: respiratory syncytial virus infection rsv